Bioimpedance spectroscopy (BIS) is a more accurate method of identifying which breast cancer survivors will need compression intervention for subclinical lymphedema compared with tape measurement (TM) to prevent chronic lymphedema, according to findings from a study published in Lymphatic Research and Biology.

 Moreover, the technology is easy to use and patient friendly, according to principal investigator Sheila H. Ridner, PhD, RN, FAAN. 

“It is as easy to use as putting someone on a scale and getting their weight,” Ridner, research professor at Vanderbilt University School of Nursing in Nashville, Tennessee, explained in an interview with Oncology Nursing News®, noting that the underlying technology is based on electrical currents that measure the fluid between the cells. “It’s very simple. It’s very quick.”

 Results from the PREVENT study (NCT02167659) showed that among patients who received compression intervention after early lymphedema detection, only 7.9% of patients who were assessed through BIS developed chronic lymphedema. In comparison, 19.2% of patients who were assessed using TM developed this chronic disease. These statistically significant results (P = .016) may translate into an absolute reduction of 11.3% and a relative reduction of 59% in lymphedema progression at 3 years, according to the study authors. 

Chronic breast cancer–related lymphedema (C-BCRL) has become more concerning as the rate of breast cancer survivorship has continued to rise. As such, the number of patients affected by pain, infections, limited arm function, reduced quality of life, and very expensive therapies because C-BCRL has likely grown in recent years. 

“To me, it is [a] numbers game,” Ridner said. “More survivors equal more opportunity for chronic pain…but if we can keep people from getting it, then there is a whole set of lymphedema-related pain issues breast cancer survivors may be able to avoid.” Currently, 5% of patients who undergo breast-conserving surgery with sentinel lymph node biopsy (SLNB) alone experience C-BCRL, as well as more than 50% of patients who undergo axillary lymph node dissection, regional node irradiation, and/or taxane-based chemotherapy. These statistics underscore the value of proper C-BCRL identification in breast cancer survivors, the authors explained. However, early-stage C-BCRL identification can be challenging. 

Although subclinical disease and extracellular fluid occurs before changes become visible, C-BCRL diagnoses do not typically occur until a visible change or symptom has become apparent. Therefore, investigators decided to use BIS to identify early-stage subclinical lymphedema and to initiate treatment to prevent C-BCRL (defined as ≥ 10% arm volume change from baseline, requiring complex decongestive physiotherapy CDP) in survivors. BIS technology can recognize extracellular fluid change and has been found to improve patient outcomes when combined with short-course compression therapy, as was administered in this study. 

“The BIS can pick up changes in the fluid that exists between each human cell. [TM] can’t do that, pyrometry can’t do that, and MRI can’t do that,” Ridner said. “The earlier you catch this fluid, the less likely you are to have a large inflammatory process in the arm. We are now able to identify the subclinical lymphedema when there is less inflammation that needs to be treated.” 

The stratified, randomized, international trial included patients with recent breast cancer diagnoses who were undergoing either mastectomy/partial mastectomy, axillary treatment (dissection, SLNB > 6 nodes or radiation), radiation therapy, or taxanebased therapy. Exclusion criteria included history of breast cancer, neoadjuvant chemotherapy, and previous radiation on the breast, chest wall, or axilla. 

Participants were randomized 1:1 following a postsurgery eligibility reassessment and underwent prospective surveillance via either BIS or TM. If surveillance detected C-BCRL, patients were to wear a class 2 (23-32 mm Hg, mediven flat-knit custom or Harmony circular knit) compression sleeve and gauntlet for 12 hours per day for 4 weeks. 

Patients were recruited between June 24, 2014, and September 11, 2018. In total, 442 evaluable patients were enrolled in the BIS cohort, and 437 evaluable patients were enrolled in the TM cohort. The median follow-up was 32.9 months. 

Presurgical measurements were collected at baseline for both the BIS or TM cohorts; collected again at 3, 6, 12, 18, 24, and 36 months; and again following compression intervention. Some sites also conducted a 15- and 21-month follow-up. 

The BIS evaluation was conducted via L-Dex U400, and TM evaluation was conducted using Gulick II tape. The patients’ arms were measured twice at 10-cm increments, starting at the wrist and continuing up to 50 cm above the wrist. A truncated cone formula was used to automatically calculate arm volume. Ultimately, the number of patients whose disease progressed following compression intervention was lower in the BIS group than the TM group (7.9%, n = 7 vs 19.2%; n = 23, relative risk, 0.41; 95% CI, 0.13-0.81; absolute reduction 11.3%; 95% CI, 2.3-20.3; P = .016). 

Notably, Ridner’s patients have expressed satisfaction with the technology. “The first patient I ever measured [with BIS] loved the technology,” she said. “Patients can tell [TM] techniques vary from therapist to therapist, doctor to doctor, or nurse to nurse. [BIS] standardizes the way you do the measurement.” 

“Surveillance with early intervention is clearly in the best interest of the patients,” Ridner said. “We can change outcomes in this population and address not only the chronicity of the lymphatic issues many of these patients have but also reduce the discomfort they may experience.”

Ridner SH, Dietrich MS, Boyages J, et al. A comparison of bioimpedance spectroscopy or tape measure triggered compression intervention in chronic breast cancer lymphedema prevention. 

. 2022;10.1089/lrb.2021.0084. doi:10.1089/lrb.2021.0084

Articles

Adverse Events Report

Patients who underwent prospective surveillance with bioimpedance
spectroscopy were less likely to develop chronic breast cancer–related
lymphedema compared with patients who were assessed with tape measure.

Bioimpedance Spectroscopy May Play a Large Role in Proactively Preventing Chronic Lymphedema

Over the past decade, there has been increased advocacy on the part of many influential voices in our profession to require the Doctor of Nursing Practice (DNP) degree for entry-level nurse practitioner roles.

In 2004, the American Association of Colleges of Nursing endorsed the posi- tion of moving from master’s training to the doctorate as the level of preparation necessary for nurse practitioners by 2018.

 In 2018, the National Organization of Nurse Practitioner Faculties changed the commitment to require the DNP as entry level for nurse practitioner practice by 2025.

Although there is not currently a requirement for the DNP for nurse prac- titioners, in keeping with this goal, many programs have already made this transition and eliminated Master of Science in Nursing (MSN) as a degree offering for nurse practitioner specialties.


The DNP was first offered in 2001 by the University of Kentucky as a mechanism to equip nurse practitioners with expanded knowledge to help them navigate a rapidly changing and increasingly complex health care environment. Expanding from fewer than 50 programs in 2006 to 357 programs in 2020, the DNP has become a highly—but not universally—sought-after achievement in nurse practitioner education.

Although the discussion on whether to require a doctorate for practitioners is not exclusive to our field, nursing is one of the few health care professions that do not require education at the doctoral level. Pharmacy, dentistry, optometry, psychology, physical therapy, occupational therapy, and audiology either require or offer doctoral-level education.

Key Points for and Against DNP Requirements


Both within and outside the profession of nursing, the calls for and against requiring a DNP have been increasingly prevalent over the past decade. Those who support the DNP for entry-level practice argue that it places nurse practitioners on education parity with other health professions. Advocates note that the DNP degree reflects the quality and rigor of education that nurse practitioners receive to provide health care.

The health care environment is more complicated than ever before and propo- nents of a DNP requirement stress the benefits additional education provides in key areas, such as evidence-based practice, quality improvement, health policy, interprofessional collaboration, and organizational leadership, better preparing nurse practitioners to practice and lead in the contemporary health care environment.

Those who oppose a mandate for the DNP argue that extant research demonstrates that nurse practitioners are contributing to effective patient care and positive clinical outcomes without a broad doctoral requirement. Research has shown that nurse practitioners are already providing high-quality care with no statistically significant difference in outcomes compared with physicians. Evidence also shows that patients cared for by nurse practitioners are more likely to receive education on health promotion and to report higher satisfaction with their care.

Opponents also cite a lack of differentia- tion between MSN- and DNP-prepared nurse practitioners, as they have the same scope of practice. Some physician organizations have noted that confusion could result for patients in clinical settings when multiple care providers, physicians and nonphysicians, identify themselves as a “doctor,” which is a concern that has been widely dismissed, as no 1 profession owns exclusive rights to the title.

It remains to be seen whether the goal of requiring a DNP by 2025 will come to fruition. However, as more nurse practitioners attain the DNP, research is needed to assess the impact of enhanced education on clinical and health system outcomes. Does the DNP make a difference in care? We can’t answer that yet.

As a senior nursing administrator for a comprehensive cancer center, I think doctoral education provides benefits that are particularly relevant and useful for nurse practitioners working with oncology populations. The number and complexity of treatment regimens today and the constant introduction of entirely novel treatment approaches, including next-generation immunotherapies and cellular therapies such as CAR T, underscore the importance of outstanding and consistent education for nurse practitioners.

Few can argue that more education for nurse practitioners would not help
to drive further improvements in health care outcomes, especially for patients with cancer—who are a vulnerable population, requiring highly complex and 

well-coordinated care. I have also seen nurse practioners play a critical role in targeting and successfully addressing ineq- uities in care and care access in rural and underrepresented communities, driving meaningful progress toward one of the most critical goals for the oncology field.

I was one of the first 300 people to earn a DNP when I earned my doctorate in 2008. Over the years, I have observed that DNP education has made me a more effective practitioner and team member.

My education helped me to better navigate the challenges and opportunities of modern oncology nursing, particularly in areas such as leading interprofessional teams, coordinating complex care, using informatics to transform health care, and advocating for equitable health policy. It helped make me a more confident and broadly informed nurse and manager. Knowing how to obtain, analyze, and integrate information is just as important for today’s nurses as professional knowledge itself.

I believe the DNP is an investment in education that gives one a foundation to provide even better care for patients, and I would recommend the doctorate for any nursing professional seeking greater professional opportunities. 

Andrew Storer, PhD, DNP, RN, NP, FAANP, is vice president of nursing and deputy chief nursing officer at Roswell Park Comprehensive Cancer Center.

1. AACN position statement on the practice doctorate in nursing. American Association of Colleges of Nursing. October 2004. Accessed February 22, 2022. https://bit.ly/3h8m2i6

2. The Doctor of Nursing Practice degree: entry to nurse prac- titioner practice by 2025. National Organization of Nurse Practitioner Faculties. May 2018. Accessed February 22, 2022. https://bit.ly/3h93e28

3. DNP fact sheet. American Association of Colleges of Nursing. Updated October 2020. Accessed February 22, 2022. https://bit.ly/35iyI34

4. Kurtzman ET, Barnow BS. A comparison of nurse prac- titioners, physician assistants, and primary care physi- cians’ patterns of practice and quality of care in health centers. Med Care. 2017;55(6):615-622. doi:10.1097/ MLR.0000000000000689

5. Newhouse RP, Stanik-Hutt J, White KM, et al. Advanced prac- tice nurse outcomes 1990-2008: a systematic review. Nurs Econ. 2011;29(5):230-251.

6. Crausman RS, McIntyre B. Use of the doctor title in clinical settings. J Med Regul. 2009;95(2):4-5. doi:10.30770/2572-1852-95.2.4

Partner Perspectives

Advocacy and opposition continue to grow regarding the National Organization of Nurse Practitioner Faculties’ goal of requiring the Doctor of Nursing Practice degree (DNP) for entry-level nurse practitioners.

Will Requiring the DNP Improve the Quality of Oncology Nursing?

Cholangiocarcinoma (CCA) and gallbladder (GB) cancers are rare types of gastrointestinal (GI) malignancies and account for 3% of all GI cancers. Each year, there are approximately 8000 new CCA and GB diagnoses in the United States.

The classification of CCA subtypes are determined by the location within the bile duct from which the tumor arises.

Intrahepatic cholangiocarcinomas (IHCCs) are tumors located within the hepatic portion of the bile ducts, whereas extrahepatic cholangiocarcinomas (EHCCs) are tumors that occur outside the liver and start at the junction of the left and right hepatic ducts, extending down to the common bile duct. EHCC can be subdivided into hilar or distal. Hilar tumors originate in the mid portion of the bile duct. GI specialists commonly refer to these as 

. In contrast, tumors that originate in the distal bile ducts are appropriately called 

Fortunately, CCAs are rare cancers, but they have a dismal prognosis. The 5-year overall survival (OS) for all stages and subtypes of CCA range between 2% and 25%.

 Because of this poor prognosis and lack of great treatment options, CCA is often fatal.



Historically, chemotherapy has been the only option for these cancers. Cisplatin (Platinol) and gemcitabine (Gemzar) represent the current standard of care to treat metastatic or unresectable disease. This has been the standard since the ABC-02 trial (NCT00262769) demonstrated that gemcitabine plus cisplatin significantly improved patient’s OS compared with gemcitabine alone in patients with biliary tract cancer (BTC).

Interestingly, one aspect of CCA that has evolved significantly over the years is our ability to identify and target proteins that are overexpressed on some CCAs. We typically target 

expression with pemigatinib (Pemazyre) or infigratinib (Truseltiq), 

 with dabrafenib (Tafinlar) and trametinib (Mekinist), 

 with entrectinib (Rozlytrek) and larotrectinib (Vitrakvi), and MSI-H with pembrolizumab (Keytruda).

Today, durvalumab (Imfinzi) represents the newest potential addition to the CCA treatment landscape. Durvalumab-related outcomes were presented at the 2022 American Society of Clinical Oncology GI Cancers Symposium as part of the TOPAZ-1 trial (NCT03875235). 

 This phase 3, randomized, double blind, placebo-controlled trial assessed the safety and efficacy of durvalumab in combination with cisplatin and gemcitabine in advanced BTCs. Eligible participants for the trial included patients with advanced IHCC, EHCC, and GB cancers, who had either not received prior therapy or had completed adjuvant therapy more than 6 months before study initiation. Patients also needed to have an ECOG status of 0 or 1.

Patients were randomized 1:1 to receive either durvalumab or placebo in addition to cisplatin and gemcitabine placebo for up to 8 cycles. Following these 8 cycles, maintenance therapy, either with durvalumab or placebo, was administered to the patients. Main study objectives included OS and progression-free survival.

Results from TOPAZ-1 showed that at a 13.7-month follow-up, the median OS was 12.8 months (95% CI, 11.1-14.0) in the durvalumab/chemotherapy arms vs 11.5 months (95% CI, 10.1-12.5) in the placebo/chemotherapy arms. Impressively, at a 24-month follow-up, OS rates were 24.9% in the study arm (95% CI, 17.9%-32.5%) and 10.4% in the control arm (95% CI, 4.7%-18.8%). Overall, the introduction of durvalumab resulted in a 20% reduction in the risk of death in this patient population (HR, 0.80; 95% CI, 0.66-0.97; 

These findings highlight a key take-home message from the trial: Although the results are modest, with no early separation of the curves, the tail of the curve is impressive. In addition, these findings suggest that by adding immunotherapy to first line chemotherapy, we can positively affect a subset of the population and impact their OS, possibly giving a small number of patients a longer disease-free interval or maybe even a cure. Identifying which patients will benefit remains a challenge.

Although CCAs are rare, they are starting to become known as one of the most targetable cancers within GI oncology, and genomic sequencing is now highly recommended for patients with unresectable or advanced BTCs. The results from the TOPAZ-1 trial will likely change clinical practice by demonstrating the potential value of immunotherapy in combination with chemotherapy for frontline treatment. We now have data showing superior outcomes for some patients, with a very acceptable safety profile.

Bile duct cancer (cholangiocarcinoma): statistics. Cancer.Net. Updated February 2022. Accessed March 1, 2022. https://bit.ly/3q9WtSC

NCCN. Clinical Practice Guidelines in Oncology. Hepitobiliary cancer, version 5.2021. guidelines: hepatobiliary cancers.Accessed March 1, 2022. https://bit.ly/36nr3Bc

Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. 

. 2010;362(14):1273-1281. doi:10.1056/NEJMoa0908721

Kam AE, Masood A, Shroff RT. Current and emerging therapies for advanced biliary tract cancers. 

. 2021;6(11):956-969. doi:10.1016/S2468-1253(21)00171-0

Oh DY, He AR, Qin S, et al. A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1. 

. 2022;40(suppl 4):378. doi:10.1200/JCO.2022.40.4_suppl.378

Clinical Insights

Adding the immunotherapy to chemotherapy in the frontline setting may improve overall survival for patients with advanced biliary tract cancer.

Durvalumab Outcomes Could Change Treatment Approaches in Cholangiocarcinoma

Niraparib/Abiraterone Combo Is Linked With Improved rPFS in Select Patients With mCRPC

Patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations who received frontline treatment with niraparib (Zejula), abiraterone acetate (Zytiga), and prednisone 

experienced superior radiographic progression-free survival

 (rPFS) compared with those who received placebo plus abiraterone/prednisone, according to findings from the phase 3 MAGNITUDE trial (NCT03748641). These findings were presented during the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium.

In the BRCA1/2 population, the median rPFS was 16.6 months with niraparib/ abiraterone vs 10.9 months with placebo/ abiraterone (HR, 0.53; 95% CI, 0.36-
0.79; P = .0014) at a median follow-up of 18.6 months. The investigator-assessed rPFS was 19.3 months with niraparib/ abiraterone and 12.4 months with placebo/ abiraterone (HR, 0.50; 95% CI, 0.33-0.75; P = .0006).


Among all patients with HRR gene alterations, the median rPFS was 16.5 months vs 13.7 months, respectively (HR, 0.73; 95% CI, 0.56-0.96; P = .0217). Here, the investigator-assessed rPFS was 19.0 months and 13.9 months, respectively (HR, 0.64; 95% CI, 0.49-0.86; nominal P = .0022).

As many as 30% of patients with mCRPC will harbor alterations in genes associ- ated with HRR. Although these alter- ations reflect poor prognosis, they have also shown increased sensitivity to PARP inhibitors, such as niraparib. Notably, the addition of an antiandrogen agent like abiraterone has been theorized to augment responses in all-comers, serving as the rationale for the randomized, double-blind MAGNITUDE trial, which evaluated the value of adding niraparib to abiraterone in patients with mCRPC with and without HRR gene alterations.

“The MAGNITUDE study results support niraparib plus abiraterone as a new first- line treatment option for patients with mCRPC and alterations in genes associ- ated with HRR,” lead study author Kim N. Chi, MD, senior research scientist at the Vancouver Prostate Centre, chief medical officer and vice president for BC Cancer, medical oncologist at BC Cancer–Vancouver, and professor in the Department of Medicine at The University of British Columbia in Canada, said in a presentation of the data.

Chi KN, Rathkopf DE, Smith MR, et al. Phase 3 MAGNITUDE study: first results of niraparib (NIRA) with abiraterone acetate and prednisone (AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations. J Clin Oncol. 2022;40(suppl 6):12. doi:10.1200/JCO.2022.40.6_suppl.012

Frontline Nivolumab Plus Cabozantinib Is Linked With Superior Quality of Life in Advanced RCC


Patients with advanced renal cell carcinoma who received the frontline combination of nivolumab (Opdivo) plus cabozantinib (Cabometyx) maintained superior health-related quality of life (HRQOL) compared with those on sunitinib (Sutent), according to

onger follow-up of the CheckMate 9ER trial

 (NCT03141177). The maintained effects, which were presented during the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium, were seen across multiple defi- nitions of deterioration, suggesting that the benefit with the combination is sustainable in the long term.

In a 32.9-month follow-up, patient- reported outcomes (PRO) scores revealed that patients receiving nivolumab/ cabozantinib had maintained or improved HRQOL compared with patients in the sunitinib arm. The longitudinal changes from baseline consequently showed statis- tical significance (P < .05) in favor of the experimental regimen for all scores except FKSI-19 functional well-being.

In the 151 weeks following baseline, patients receiving nivolumab/cabozantinib experienced a –0.47 least square (LS) mean change from baseline FKSI-19 total score compared with a –2.84 decline with those in the sunitinib arm (overall difference in mean change, 2.37; P < .0001). For the FKSI-19 disease-related symptoms score, patients receiving nivolumab/cabozantinib experienced an LS mean change from base- line of 0.71 compared with –0.46 in the sunitinib arm (1.17; P < .0001).

Similarly, patients receiving nivolumab/ cabozantinib experienced an EQ-5D-3L health status score of 2.73 compared with –0.95 in the sunitinib group (3.68; P = .0001). The EQ-5D-3L UK utility index score demonstrated that patients receiving nivolumab/cabozantinib experienced an LS mean change from baseline of –0.01 compared with –0.06 in the sunitinib arm (0.05; P = .001).

At baseline, both arms demonstrated a high PRO completion rate of at least 90%. By week 151, the rates were over 75% and 73% in the nivolumab/cabozantinib and sunitinib arms, respectively. At baseline, both arms demonstrated relatively low symptom burden.

“At nearly 3 years of follow-up, patients continued to report improved HRQOL with nivolumab/cabozantinib compared with sunitinib,” lead study author and coinvestigator David Cella, FASCO, PhD, chair of the Department of Medical Social Sciences and director of the Institute for Public Health and Medicine at Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago, Illinois, wrote in a poster presentation of the findings. “Treatment with [nivolumab/ cabozantinib] was observed to reduce the risk of clinically meaningful deterioration in HRQOL scores in comparison with suni- tinib, regardless of definition of deterioration.”

Cella D, Motzer RJ, Blum SI, et al. Health-related quality of life (HRQoL) in previously untreated patients with advanced renal cell carcinoma (aRCC): CheckMate 9ER updated results. J Clin Oncol. 2022;40(suppl 6):323. doi:10.1200/ JCO.2022.40.6_suppl.323

Darolutamide Prolongs OS in Patients With Nonmetastatic CRPC Plus Comorbidities and Concomitant Medications

Darolutamide (Nubeqa), an androgen receptor inhibitor,

yielded positive responses in patients with nonmetastatic castration-resistant prostate cancer

(CRPC), who were also being treated with concomitant medications or had comorbidities, according to phase 3 data presented at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium.

Patients with nonmetastatic CRPC from the ARAMIS trial (NCT02200614) were randomized 2:1 to receive either darolutamide (n = 955) or placebo (n = 554) while continuing treat- ment with androgen deprivation therapy.

At the final data cutoff date of November 15, 2019, overall survival (OS) and adverse events were evaluated in patients with a median of 6 or fewer or more than 6 comorbidities and 10 or fewer or more than 10 concomitant medications. Comorbidities evaluated included metabolic, cardio- vascular (CV), and other (osteoarthritis, arthralgia, back pain, benign prostatic hyperplasia, constipation, gastroesoph- ageal reflux, and renal insufficiency).

Concomitant medication classes/subclasses included gastrointestinal/metabolic, CV (antihypertensives and nonantihyperten- sives), pain/inflammation, and urologic.

“[Over] 50% of the patients in the ARAMIS trial, which was a very significant number of patients...had a minimum of 6 or more comorbidities of significance,” study coauthor Neal Shore, MD, FACS, US Chief Medical Officer of Surgery and Oncology at GenesisCare USA, and director of the Carolina Urologic Research Center, said in a presentation during the meeting. Specifically, 795 of the total cohort of 1509 patients had at least 6 comorbidities, and 813 patients had received at least 10 concomitant medications.

The investigators reported that, in patients with at least 6 and more than
6 comorbidities, darolutamide prolonged OS compared with placebo (HR, 0.65 and 0.73, respectively). The OS benefit for darolutamide was found to be consistent in patients with metabolic, CV, and other comorbid disorders (HR range, 0.39-0.88). OS was also prolonged in patients receiving at least 10 and more than 10 concomitant medications (HR, 0.76 and 0.66, respectively).

“Subgroups of [patients] receiving concomitant medications for gastrointes- tinal/metabolic disorders, CV disease, urologic disorders, and pain/inflammation achieved similar OS benefit with [darolut- amide vs placebo] with an [HR range of 0.45–0.80],” the authors wrote.

“What we’re showing here is that the OS benefit [and] the safety analysis [were rather significant], regardless of the number of comorbidities,” Shore said.

Fizazi K, Shore ND, Smith MR, et al. Efficacy and safety outcomes of darolutamide in patients with nonmeta- static castration-resistant prostate cancer with comor- bidities and concomitant medications from ARAMIS. J Clin Oncol. 2022;40(suppl 6):256. doi:10.1200/ JCO.2022.40.6_suppl.256


Neoadjuvant Enfortumab Vedotin Shows Potential in Cisplatin-Ineligible Muscle- Invasive Bladder Cancer


Patients with muscle-invasive bladder cancer (MIBC) who were not eligible for cisplatin 

experienced promising antitumor responses after receiving neoadjuvant enfortumab vedotin

(Padcev), according to preliminary findings from cohort H of the phase 1b/2 EV-103 trial (NCT03288545). These findings were presented during the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium.

Investigators reported a pathological complete response rate of 36.4% (95% CI, 17.2%-59.3%) among those treated with enfortumab vedotin (n = 22) and a pathological downstaging rate of 50.0% (95% CI, 28.2%-71.8%).

“This first disclosure of data support the ongoing phase 2 and 3 programs evaluating enfortumab vedotin alone or in combi- nation with pembrolizumab (Keytruda) in MIBC,” lead study author Daniel P. Petrylak, MD, professor of medical oncology and urology at the Yale Cancer Center in New Haven, Connecticut, said in a presentation of the data.

Patients received 1.25 mg/kg of neoad- juvant enfortumab vedotin monotherapy on days 1 and 8 per 21-day cycle for 3 cycles. Within 4 weeks of treatment, patients underwent radical cystectomy plus pelvic lymph node dissection, followed by imaging every 12 weeks for the first 2 years, then every 24 weeks after.

The most common reason for cisplatin ineligibility was creatinine clearance between less than 60 and 30 or more mL per minute (50.0%), followed by grade 2 or greater hearing loss (40.9%). A total of 86% of patients completed all 3 cycles of neoadjuvant therapy.

Any-grade enfortumab vedotin–related treatment-emergent adverse events (TEAEs) were seen in all patients. Common TEAEs included fatigue (45.5%), alopecia (36.4%), dysgeusia (36.4%), diarrhea (27.3%), nausea (27.3%), peripheral sensory neuropathy (27.3%), dry eye (22.7%), and maculopap- ular rash (22.7%). Four patients experienced grade 3 or higher TEAEs, and no grade 4 TEAEs or deaths were reported. Grade 3 TEAEs related to treatment with enfortumab vedotin included asthenia, dehydration, erythema multiforme, and hyperglycemia.

In the safety analysis, 3 enfortumab vedotin–related TEAEs leading to dose interruptions, 2 TEAEs leading to dose reductions, and 3 TEAEs leading to discon- tinuations were observed. Most adverse events (AEs) of special interest were grade 1 and 2. Any-grade AEs of interest included peripheral neuropathy (36.4%), skin reac- tion (63.6%), hyperglycemia (22.7%), ocular disorder (40.9%), and infusion-re- lated reactions (9.1%). Grade 3 or greater AEs of special interest were skin reactions (9.1%) and hyperglycemia (13.6%).

“The observed safety profile of neoad- juvant enfortumab vedotin monotherapy in patients with cisplatin-ineligible MIBC is consistent with the known AE profile of enfortumab vedotin in other settings,” Petrylak said.

Petrylak DP, Flaig TW, Mar N, et al. Study EV-103 cohort H: antitumor activity of neoadjuvant treatment with enfor- tumab vedotin monotherapy in patients (pts) with muscle invasive bladder cancer (MIBC) who are cisplatin-inel- igible. J Clin Oncol. 2022;40(suppl 6):435. doi:10.1200/ JCO.2022.40.6_suppl.435

PARP inhibitors emerge as frontline treatment in metastatic castration-resistant prostate cancer, immunotherapy combinations improve quality of
life in advanced renal cell carcinoma, and antibody drug conjugates show promise in cisplatin-ineligible urothelial cancer.

Nurse Takeaways: 2022 ASCO Genitourinary Cancers Symposium at a Glance

Trastuzumab Deruxtecan Improves OS in Select Gastric/GEJ Cancer


Updated trial survival results from the phase 2 DESTINY-Gastric01 trial (NCT03329690) revealed that fam-trastuzumab deruxtecan-nxki (Enhertu) 

reduced mortality rates by 40% compared with standard chemotherapy

among patients with HER2-positive gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma. The data were presented during the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

The updated median overall survival (OS) with trastuzumab deruxtecan remained at 12.5 months (95% CI, 10.3-15.2) compared with 8.9 months (95% CI, 6.4-10.4) with chemotherapy (HR, 0.60; 95% CI, 0.42-0.86).

In January 2021, the FDA approved trastu- zumab deruxtecan for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarci- noma who have received a previous trastu- zumab (Herceptin)-based regimen.

“With continued follow-up after the primary analysis, trastuzumab deruxtecan demonstrated a clinically meaningful OS benefit and clinically relevant improve- ment in [objective response rate] compared with standard chemotherapy in HER2- positive advanced gastric or GEJ cancer,” lead study author Kensei Yamaguchi, MD, of The Cancer Institute Hospital of the Japanese Foundation for Cancer Research in Tokyo, Japan, said in a presentation during the meeting.

Yamaguchi K, Bang YJ, Iwasa S, et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2–positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: final overall survival (OS) results from a randomized, multicenter, open-label, phase 2 study (DESTINY-Gastric01). 

. 2022;40(suppl 4):242. doi:10.1200/JCO.2022.40.4_suppl.242

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas. News release. FDA; January 15, 2021. Accessed January 15, 2021. http://bit.ly/35KBZ8T

Ivosidenib Maintains Quality of Life in Patients With Cholangiocarcinoma 

promising preservation of health-related quality of life 

among patients with advanced chemotherapy-refractory cholangiocarci- noma and an IDH1 mutation, according to a long-term follow-up of the ClarIDHy study (NCT02989857). The data were presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

Investigators specifically assessed how the oral targeted therapy impacted patients’ physical function, pain, and appetite loss compared with placebo. In terms of phys- ical function, the changes between baseline and 27 days of treatment did not reach the prespecified 12- to 13-point threshold— marking a lack of clinically meaningful decline among those treated with ivosidenib.

However, patients who received placebo demonstrated clinically meaningful dete- rioration across multiple cycles. Similarly, for pain, appetite loss, and eating, the least square means of change were reported for patients receiving ivosidenib compared with those on placebo.

“Cholangiocarcinoma is a rare and aggressive cancer, and treatment options
are primarily limited to chemotherapy. Mutations in the IDH1 protein have been found to occur in approximately 1% to 3% of intrahepatic cholangiocarcinomas and 1% of extrahepatic cholangiocarcinomas globally,” Christina X. Chamberlain, PhD, of Servier, explained in a presentation of the findings.

“Overall, patients who remain on ivosid- enib tend to maintain their health-related quality of life based on the least squares mean changes over time from baseline through cycle 27, day 1, which corresponds approximately to year 2,” she said.

Chamberlain CX, Hua Z, Gliser C, et al. Longitudinal trends in health-related quality of life (HRQoL) among patients treated with ivosidenib (IVO) for 

-mutated cholangiocarcinoma (CCA) in the ClarIDHy study. 

. 2022;40(suppl 4):388. doi:10.1200/JCO.2022.40.4_suppl.388

Adding Nivolumab to Encorafenib/ Cetuximab Yields High Response Rates in MSS, BRAF V600E+ Metastatic CRC 

Patients with refractory microsatellite stable, BRAF V600E–mutant metastatic colorectal cancer 

experienced high response rates and manageable adverse events 

after receiving nivolumab (Opdivo) in addition to encorafenib (Braftovi) plus cetuximab (Erbitux), according to data from a phase 1/2
trial (NCT04017650), presented during the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

The results highlighted an overall response rate of 50% (95% CI, 28%-72%) among those treated with the combina- tion, with all patients achieving partial responses. The disease control rate was 96% (95% CI, 77%-100%).

“Encorafenib, cetuximab, and nivolumab appears to be a safe and well-tolerated combination,” lead study author Van K. Morris, MD, an assistant professor in the Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, said during a presentation of the data. “The efficacy of this combination appears promising when considering the precedent of encorafenib and cetuximab alone from the previ- ously reported BEACON [CRC] study [NCT02928224].”

The study regimen included a 300-mg dose of oral encorafenib that was administered daily, 500 mg/m2 of cetuximab intravenously every 14 days, and 480 mg of nivolumab intravenously every 28 days.

Morris VK, Parseghian CM, Escano M, et al. Phase I/II trial of encorafenib, cetuximab, and nivolumab in patients with microsatellite stable, BRAF V600E metastatic colorectal cancer. 

. 2022;40(suppl 4):12. doi:10.1200/JCO.2022.40.4_suppl.012

Ivosidenib maintains quality of life in cholangiocarcinoma, immunotherapy outperforms chemotherapy in select gastric/gastroesophageal junction adenocarcinoma, and nivolumab induces high response rates are observed among patients with BRAF V600E–mutant metastatic colorectal cancer.

2022 ASCO Gastrointestinal Cancers Symposium Highlights

No system can properly flourish without constant efforts to diversify, and the nursing field is no exception. In this issue, our cover story takes a hard look at the current statistics regarding diversity in nursing and provides some clear perspectives on how these numbers impact patient outcomes. In addition, our Medical Economics® column piggybacks off the question of equity by raising awareness about how the language of electronic health records may unin- tentionally help perpetuate implicit biases.

Inclusion and accessibility walk hand in hand. Our feature story delves into newly launched “decentralized clinical trials” that represent a novel approach to bringing cancer treatment to the patient. In this initiative, patients will be provided with virtual treatment options to make their therapy more accessible, as well as to improve clinical trial enrollment and retention.

Moreover, our Nurse’s Note addresses the concept of total pain. Patricia Jakel, MN, RN, AOCN, a clinical nurse specialist in the Solid Tumor Program at University of California Los Angeles (UCLA) Santa Monica Medical Center in California and co–editor-in-chief of Oncology Nursing News®, presents a case study on total pain management, concluding that although addressing patients’ physical discom- fort may be obvious, it can be easy to neglect the psychological pain they are simultaneously experiencing. Jakel argues that it is the responsibility of oncology nurses to be mindful of the full scope of pain a patient is undergoing to provide them with the necessary care. 

Similarly, this issue’s episode of The Vitals includes a conversation with Janice Post-White, PhD, RN, FAAN. Post-White continues the discussion on emotional and psychological pain by addressing how she balanced working as an oncology nurse through her child’s cancer diagnosis.

By sharing lessons learned from her experience, Post-White reflects on some of the inter- sections of her professional and personal life and offers advice for those processing their own grief in the wake of cancer.

As always, we strive to keep you informed of the most relevant changes in the field of oncology. In this issue, we feature the recent approvals of tebentafusp-tebn (Kimmtrak) and pacritinib (Vonjo). Tebentafusp was approved in January 2022 for the indication of patients with unresectable or metastatic uveal melanoma in adult patients whose disease harbors HLA-A*02:01 and represents the first FDA-approved therapy to treat this patient population. Pacritinib received accelerated approval in February 2022 for the treatment of adult patients with intermediate-or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofi- brosis and severe thrombocytopenia (platelet counts less than 50 × 109/L). Regular approval will be contingent on findings from the newly launched PACIFICA trial (NCT03165734).

Moreover, our Clinical Insights column provides a quick snapshot of practice-changing research presented at the 2022 Gastrointestinal (GI) and Genitourinary (GU) Cancers Symposiums. Data from the GI Cancers Symposium highlighted the efficacy with checkpoint inhibitors in biliary tract cancer. Kristin E. Barber, APRN, AOCNP, FNP-BC, a nurse practitioner of GI Oncology at Huntsman Cancer Institute and Hospital with the University of Utah, offers some insights into the significance of the phase 3 TOPAZ-1 trial (NCT03875235) and what the findings could represent for this patient population. Also in this meeting, immunotherapy repeatedly outperformed chemotherapy in select gastric/gastroesophageal junction adenocarcinoma, and high response rates were observed among patients with BRAF V600E– mutant metastatic colorectal cancer who received a triplet regimen of nivolumab, encorafenib, and cetuximab. Another notable outcome included an observed positive relationship between ivosidenib (Tibsovo) and maintained quality of life in cholangiocarcinoma. This year’s GU Cancers Symposium included data showing potential for PARP inhibitors as the new frontline treatment in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations. Other key takeaways show that immunotherapy combinations are linked with improved quality of life in advanced renal cell carcinoma, that darolutamide (Nubeqa) prolongs overall survival in select patients with prostate cancer, and that enfortumab vedotin (Padcev) shows promise in cisplatin-ineligible muscle-invasive bladder cancer.

As we all well know, comprehensive cancer care includes addressing indirect complications—our Adverse Event Report highlights research demonstrating that using bioimped- ance spectroscopy instead of a tape measure yields more accurate signs of lymphedema in breast cancer survivors. Coupled with early intervention with a compression sleeve, these findings could play a vital role in reducing the number of survivors who need to endure chronic breast cancer–related pain, explains Sheila Ridner, PhD, RN, FAAN, research professor of Nursing at Vanderbilt University School of Nursing in Nashville, Tennessee, in an interview with 

Our Advanced Practice Providers page addresses another common component
of cancer care: bone marrow transplant. Elizabeth Boateng, MSN, RN, FNP-BC, OCN, of Hackensack Meridian John Theurer Cancer Center in New Jersey, provides an overview of important safety considerations for oncology nurses to consider when caring for immunocompromised patients with hematologic malignancies.

Lastly, as advocacy and opposition continue to grow regarding the National Organization of Nurse Practitioner Faculties’ goal of requiring the doctor of nursing practice degree (DNP) as entry level for nurse practioner practice, Andrew Storer, PhD, DNP, RN, NP, FAANP, of Roswell Park Comprehensive Cancer Center in Buffalo, New York, highlights arguments for and against the requirement, offering his opinion on whether this requirement can improve the quality of care that oncology nursing brings to the field. 

No system can properly flourish without constant efforts to diversify, and the nursing field is no exception.

Questions of Accessibility and Inclusion Continue to Draw Attention in Oncology Nursing

The language used to describe patients in electronic health records (EHR) may be perpetuating racial bias and other negative stereotypes in health care, according to a study recently published in 

 A multi- disciplinary team of investigators from the University of Chicago used machine learning techniques to analyze potentially stigmatizing language across more than 40,000 history and physical notes in EHRs made up of 18,459 adult patients and 33,142 unique encounters at an academic medical center in Chicago, Illinois, between January 2019 and October 2020. They determined Black patients were 2.54 times more likely than White patients to be described in negative terms (95% CI, 1.99-3.24). Negative terms included refused (n = 1461), (not) adherent (n = 605), (not) compliant (n = 561), and agitated (n = 409). Findings were adjusted for sociodemographic and health characteristics.

Moreover, the differences were not solely based on race. For example, Medicare and Medicaid beneficiaries were more likely to have negative descriptors applied to them than were patients with commercial- or employer-based insurance (Medicare: adjusted odds ratio [AOR], 2.08; 95% CI, 1.57-2.75) (Medicaid: AOR, 2.66; 95% CI, 2.08-3.40), as were unmarried patients (AOR, 2.12; 95% CI, 1.70-2.65) compared with patients who were married.

Evaluable patients were patients with at least 1 charted history or physical note in their EHR when they were admitted to an inpatient setting or emergency department or visited an outpatient setting. These notes are designed to document the patient’s reason for seeking medical care; provide a summary of medical, family, and social history; and lay out the prescribed care plan to address the medical problem. The investigators chose to center their research on the history and physical note because it is designed to create a comprehensive narrative of the patient’s experience, which will be used by other health care professionals. If a patient had multiple history and physical notes, all available notes were extracted and included for analysis.

The findings are especially troubling, given that other studies have found that less than 20% of text in inpatient progress notes are original,

 with most of the rest being imported from prior documentation. As a result, “subsequent providers may read, be affected by, and perpetuate the negative descriptors, reinforcing stigma to other health care teams,” the authors wrote. “Negative descriptors written in the admission history and physical may be likely to
be copied into subsequent notes, recommunicating and amplifying potential biases. This practice underscores the responsibility of providers who document the initial patient encounter to do so in an aware and sensitive manner.”

Furthermore, the investigators found that notes written for outpatient visits were less likely to have negative descriptors included in the patient’s EHR than inpatient encoun- ters (31% vs 68%). They theorize that this may result from inpatient settings being inherently more stressful, thereby increasing the risk of doctors using stereotypes as “cognitive shortcuts.” They also found that race-based differences in the use of negative descriptors narrowed after March 1, 2020.

Nevertheless, the authors agreed that fixing the problem will require medical 

institutions to better address the issue of implicit racial bias among providers. They cite the example of 1 physician’s use of the term “aggressive” as reflecting the physi- cian’s personal bias regarding Black men. Once such a negative label becomes part of the patient’s record, “it potentially affects the perceptions and decisions of future providers, regardless of whether future providers hold a bias about Black men being aggressive,” they wrote.

Regulatory bodies, such as the Accreditation Council for Graduate Medical Education, might also develop specific recommendations for the use of nonstigmatizing, patient-centered language to prevent the transmission of bias, they suggest. The study concludes that the need is especially important in light of the OpenNotes policies that medical institutions are adopting, which allow patients full access to their EHRs, including chart notes. Without paying attention to the language used to describe patients, providers risk “harming the patient-provider relationship, with downstream effects on patient satisfaction, trust, and even potential litigation.”

Sun M, Oliwa T, Peek ME, Tung EL. Negative patient descriptors: documenting racial bias in the electronic health record.

. 2022;41(2):203-211. doi:10.1377/hlthaff.2021.01423

Wang MD, Khanna R, Najafi N. Characterizing the source of text in electronic health record progress notes. 

 2017;177(8):1212-1213. doi:10.1001/jamainternmed.2017.1548

Medical Economics

Fixing the problem will involve holding medical institutions accountable for addressing implicit bias among providers.

Electronic Health Record Notes May Be Perpetuating Biases

Bone marrow transplantation (BMT) is a common treatment for advanced hematologic malignancies. During the process, the patient’s hematologic system is eradicated using chemotherapy and radiation therapy. The type of transplant a patient receives is dependent on their diagnosis and/or comorbidities.

An autologous transplant will require mobilization of stem cells. This is achieved by administration of chemotherapy and/or growth factors. Recovery is usually quicker with less complications. Allogeneic transplant is replaced with healthy hematopoietic cells from a human leukocyte antigen–matched donor to constitute a new blood-forming system. The lengthy process can be grueling, and BMT recipients typically become immunocompromised. As a result of myelosuppression, patients are at increased risk of neutropenia.

Special protocols are required to minimize the patient’s risk of infection and to treat or prevent adverse effects. Oncology nurses typically provide prophylactic anti-infection measures and educate patients and caregivers about the protocols they must follow. These measures may include the following:

Antimicrobials such as ciprofloxacin (CiproXR), penicillin v potassium, and trimethoprim-sulfamethoxazole (Bactrim) given prophylactically

Antivirals such as acyclovir (Sitavig, Zovirax), valacyclovir (Valtrex), and ganciclovir (Zirgan) to prevent herpes simplex virus and cytomegalovirus infections

Antifungals, including fluconazole (Diflucan), voriconazole (Vfend, Vfend IV), and posaconazole (Noxafil)

Antiemetics to prevent or treat nausea and vomiting

Electrolyte supplements to maintain normal potassium, magnesium, calcium, and phosphorus levels

Granulocyte colony-stimulating factor is given to shorten the time to engraftment

Transfusions of red blood cells and platelets in the early posttransplant period to treat thrombocytopenia and anemia until the bone marrow graft begins to produce new blood cells

Inflammation or excoriation of the oral mucosa and the gastrointestinal tract because of pretransplant chemotherapy or radiation therapy manifests as stomatitis and dysphagia, which can reduce quality of life, prolong the hospital stay, and raise infection risk. Antioral mucositis measures include the following:

Cryotherapy (ice chips or ice pops) before, during, and after melphalan administration for a total of 2 hours to induce vasoconstriction and slow melphalan absorption

Calcium phosphate (Caphosol) mouth rinse and Magic Mouthwash (diphenhydramine [Benedryl], aluminum hydrozide/magnesium hydroxide/simethicone [Mylanta], and lidocaine viscous) to soothe the oral mucosa

Preventive treatment should start before chemotherapy or radiation treatment and continue as needed.

Use antiemetics as needed and replete fluids and electrolytes. Patients may benefit from eating smaller meals more frequently, avoiding fatty foods, eating drier foods with fluids in between, and consuming saltier foods, such as crackers and pretzels.

. Use antidiarrheal medications and replete fluids/electrolytes as needed. High-fiber foods, nuts, seeds, fatty or fried foods, spicy foods, caffeinated beverages, foods containing sorbitol or lactose, and sugar substitutes should be limited. Daily fluid intake should be 8 to 10 cups.

Patients should consult with a registered dietitian before, during, and after transplant as needed.

Maintaining good oral hygiene helps improve the taste of foods. Patients may enjoy tart foods, such as lemon, yogurt, and pineapple.

Prevention and Treatment of Complications

Special protocols are required to ensure the safety of patients undergoing bone marrow transplants.

April 2022

Bioimpedance Spectroscopy May Play a Large Role in Proactively Preventing Chronic Lymphedema

Will Requiring the DNP Improve the Quality of Oncology Nursing?

Durvalumab Outcomes Could Change Treatment Approaches in Cholangiocarcinoma

Nurse Takeaways: 2022 ASCO Genitourinary Cancers Symposium at a Glance

2022 ASCO Gastrointestinal Cancers Symposium Highlights

Questions of Accessibility and Inclusion Continue to Draw Attention in Oncology Nursing

Electronic Health Record Notes May Be Perpetuating Biases

Caring for an Immunocompromised Bone Marrow Transplant Recipient

Understanding “Total Pain” in the Context of Oncology Care

Decentralized Clinical Trials: Bringing Care Directly to Patients

The Future of Nursing Must Be Diverse